combination chemotherapy and radiation therapy in treating patients with limited-stage small cell lung cancer

Conditions: Lung Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. radiation therapy uses high-energy x-rays to damage tumor cells. combining chemotherapy and radiation therapy may kill more tumor cells. purpose: phase ii trial to study the effectiveness of combination chemotherapy and radiation therapy in treating patients who have limited-stage small cell lung cancer.

objectives: * determine the complete and overall response rates in patients with limited stage small cell lung cancer treated with induction chemotherapy comprising paclitaxel, topotecan, and etoposide followed by consolidation chemoradiotherapy. * determine the toxicity of this regimen in these patients. * determine the overall and failure-free survival of patients treated with this regimen. * determine the overall (partial and complete) response rate in patients treated with this induction chemotherapy regimen. outline: this is a multicenter study. * induction therapy: patients receive paclitaxel iv over 3 hours on days 1 and 22, oral topotecan on days 2-4 and 23-25, and oral etoposide on days 5-7 and 26-28. patients also receive filgrastim (g-csf) subcutaneously daily beginning on days 8 and 29 and continuing until blood counts recover. * consolidation therapy: patients receive carboplatin iv over 1 hour on days 43, 64, and 85 and etoposide iv over 1 hour on days 43-45, 64-66, and 85-87. patients undergo radiotherapy daily 5 days per week beginning on day 43 and continuing for 6-7 weeks. patients with rapid disease progression discontinue study therapy. patients are followed at least every 3 months for 2 years, every 6 months for 3 years, and then annually for 5 years. projected accrual: a total of 25-60 patients will be accrued for this study within 10 months.

Eligibility criteria:
disease characteristics: * histologically or cytologically confirmed small cell lung cancer * limited stage defined as disease restricted to one hemithorax with regional lymph node metastases including hilar, ipsilateral, and contralateral mediastinal lymph nodes * measurable disease * at least 20 mm by conventional techniques or * at least 10 mm by spiral ct scan * lesions not considered measurable include the following: * bone lesions * leptomeningeal disease * ascites * pleural/pericardial effusion * abdominal masses not confirmed and followed by imaging techniques * cystic lesions * tumor lesions in a previously irradiated area * no clinically suspected or confirmed supraclavicular lymph node metastases * no pleural effusions visible on plain chest radiographs, regardless of cytology patient characteristics: age: * 18 and over performance status: * ecog 0-2 life expectancy: * not specified hematopoietic: * granulocyte count at least 1,500/mm3 * platelet count at least 100,00/mm3 hepatic: * bilirubin less than 1.5 mg/dl * sgot less than 2 times upper limit of normal (uln) renal: * creatinine no greater than uln * creatinine clearance no greater than 150 ml/min for men or 130 ml/min for women other: * not pregnant or nursing * fertile patients must use effective contraception * no other currently active malignancy except non-melanoma skin cancer * patients must have completed therapy for any other malignancy and be considered to be at less than 30% risk of relapse prior concurrent therapy: biologic therapy: * no concurrent filgrastim (g-csf) during consolidation therapy chemotherapy: * no prior chemotherapy for small cell lung cancer * no other concurrent chemotherapy endocrine therapy: * no concurrent hormonal therapy except: * steroids for adrenal failure * hormones for non-disease-related conditions (e.g., insulin for diabetes) * intermittent use of dexamethasone as an antiemetic or as an adjunct to prophylactic cranial irradiation radiotherapy: * see disease characteristics * no prior chest radiotherapy surgery: * not specified

Keywords: limited stage small cell lung cancer